Why is tibolone discontinued in the US?

Why is tibolone discontinued in the US?

US regulators have rejected Organon’s enzyme replacement therapy Livial (tibolone) for the treatment of menopausal symptoms in women, prompting the company – the human healthcare unit of Dutch concern Akzo Nobel – to withdraw its application in the country.

What is the difference between tibolone and Livial?

Livial is different from other HRT. Instead of actual hormones (such as oestrogen and progestogen) it contains tibolone. Your body breaks down tibolone to make hormones. Its effects and benefits are similar to combined HRT.

How long can you stay on Livial?

Review the need for continuation of treatment after 6 months, taking into account the risk-benefit ratio for the individual user at that moment. A separate progestogen should not be added with Livial treatment.

Is tibolone better than HRT?

Tibolone was generally well-tolerated and the overall continuation rate was significantly higher. It seems that tibolone can be an appropriate choice for HRT due to lower rates of bleeding/ spotting episodes and higher acceptance rate in postmenopausal women.

How long can I stay on tibolone?

The duration of treatment in these studies ranged from 2 months to 4.5 years. Table 1 shows the undesirable effects that occurred statistically significantly more frequently during treatment with Tibolone than with placebo.

Can you take tibolone long term?

No evidence indicates that tibolone increases the risk of other long-term adverse events, or that it differs from HT with respect to long-term safety. Much of the evidence was of low or very low quality. Limitations included high risk of bias and imprecision.

Is Livial a steroid?

Tibolone (Livial®; Organon, Oss, the Netherlands) is a synthetic steroid with estrogenic, progestagenic, and androgenic properties.

What is the best time of day to take tibolone?

Take one 2.5 mg tablet every day. You may take tibolone at whatever time of day you find easiest to remember, but try to take your doses at the same time of day, each day. You can take the tablets before or after meals. You may find it helps to swallow the tablet with a drink of water.

Is tibolone an androgenic?

A large number of studies suggest that tibolone may improve sexual function. This is plausible because testosterone (T) has been shown to increase libido and frequency of sexual activities, and tibolone has androgenic activity. Specifically, as noted earlier, the Δ4-isomer of tibolone stimulates the androgen receptor.

Does tibolone help anxiety?

In our study, we found that tibolone was superior to placebo in anxiety and Kupperman index scores. In menopausal women, the psychological benefits of HT may occur because of the relief of vasomotor symptoms and a reduction in vaginal dryness, and this is known as the ‘domino effect’ (2).

How many years can you take tibolone?

Does Livial make you put on weight?

Overall tibolone was well tolerated and climacteric symptoms were relieved within 3-5 weeks. The major side effect was weight gain and/or a tendency to bloating and oedema which occurred in 11.28% of our women.